There are many types of devices and methods for treating male urinary incontinence using external penile appliances. A spring loaded, external penile device is discussed in two articles: See Urinary Incontinence: Control by External Device, Archives of Physical Medicine and Rehabilitation, August, 1973, Vol. 54, pp. 376-378 and An External Device for Management of Male Urinary Incontinence, J. Biomechanics, 1972, Vol. 5, pp. 257-260.
At least four such devices are currently being marketed: 1) Cunningham Clamp--Bard Home Health Care Division, C. R. Bard, Inc., Berkley Heights, N.J. 07922; 2) Baumrucker Clamp--Greenwald Surgical Co., Inc., 2688 DeKalb St., Lake Station, Ind. 46405; 3) Penoring Clamp--Koken Co., Ltd., Tokyo, Japan; and 4) Cook Continence Cuff--VPI, A Cook Group Company, 127 South Main Street, Spencer, Ind. 47460.
Known U.S. patents are U.S. Pat. Nos. 4,102,342; 3,866,611; 3,203,421; 3,155,096; 3,147,754; 2,756,753; 2,618,270; 2,533,924; and 1,728,322.
There are several disadvantages associated with many existing devices and methods for treating male urinary incontinence using an external penile appliance. One typical problem is that these devices often tend to restrict the blood supply to the penile shaft which can cause discomfort to the user and in extreme cases can result in tissue necrosis. This is due in part because many of these devices restrict the penile shaft between two relatively flat, narrow, and rigid members.
Yet another problem with many existing devices is that they orient the hinge axis parallel to the axis of the penile shaft. This often results in uneven pressure zones on the penile shaft. In particular, devices with a parallel hinge axis orientation typically apply pressure on the tissue positioned closest to the hinge.
Yet another problem with many existing devices is they are sensitive to tension adjustment such that the tension affects the force applied by the device to the penile shaft. Thus it is possible for the user to inadvertently tighten the device too much such that the blood supply to the penis is restricted.
Many existing devices are bulky and difficult for the user to conceal. Snaps, hooks, buckles, nonelastic tape, etc. which are used to attach the devices to the penile shaft are often uncomfortable and a source of irritation.
Additionally, the cost of existing devices is often too expensive to be disposable after a period of use or when becoming soiled. Failure to replace these devices because of soiling can result in reduced personal hygiene and patient safety.
The present invention solves these and other problems associated with the prior art.